different designs if the strengths of one complement the weaknesses of another. Classic RCTs, for example, will provide strong evidence of cause-and-effect relationships in carefully controlled circumstances, but ideally, the results would be complemented by the results of outcomes or effectiveness studies if the fundamental questions have to do with treatment effectiveness in real-world practice settings (IOM, 1999; Jonas and Linde, 2002).

The use of a variety of study designs to produce a rich, complementary body of evidence for specific treatments or modalities is a desirable approach, but in practice, only limited amounts of money and time are available for effectiveness studies. Study sponsors may have to choose between traditional and innovative study designs, at least at any one point in time, if trials are expensive and budgets are limited.

In those circumstances, trade-offs need to be examined in the context of the question(s) being addressed. If the fundamental question is one of safety, then a surveillance design capable of picking up rare but serious events is indicated. If the therapy is relatively new and unknown and the key questions have to do with efficacy, then a traditional RCT design would fit. If efficacy is accepted but the questions to be addressed have to do with effectiveness across a range of providers and settings, then a large outcomes study aimed at identifying determinants of good and poor outcomes may be indicated. If the key questions have to do with cost-effectiveness, then a more tightly focused outcomes study (i.e., one with fewer patients, providers, or treatment sites) that includes explicit collection of cost data will be required.

For many treatments, the results of RCTs or other types of clinical studies are the culmination of a much larger sequence of basic research studies that grow out of, contribute to, and increase the understanding of fundamental biological mechanisms of illness. Clinical trials of newer therapies for peptic ulcer, for example, were built on years of basic research on the roles of bacteria and acids in the generation of ulcers. Clinical trials of statins for the treatment of cardiovascular disease were based on years of basic research on the role of cholesterol in cardiovascular disease, and studies of new treatments based on reducing inflammation in coronary arteries will follow basic research on the role of inflammatory processes in the progress from coronary artery disease to acute myocardial infarction.

A crucial synergy exists between basic and clinical research. Basic research seeks to expand knowledge and understanding of the biological mechanisms of illness and treatment. Much of clinical research builds on the results of basic research to determine whether treatments based on new

Front Matter (R1-R22)

Executive Summary (1-12)

1 Introduction (13-33)

2 Prevalence, Cost, and Patterns of CAM Use (34-73)

3 Contemporary Approaches to Evidence of Treatment Effectiveness: A Context for CAM Research (74-107)

4 Need for Innovative Designs in Research on CAM and Conventional Medicine (108-128)

5 State of Emerging Evidence on CAM (129-167)

6 An Ethical Framework for CAM Research, Practice, and Policy (168-195)

7 Integration of CAM and Conventional Medicine (196-225)

8 Educational Programs in CAM (226-252)

9 Dietary Supplements (253-277)

10 Conclusion (278-282)

Appendix A: CAM Therapies, Practices, and Systems (283-292)

Appendix B: Consortium of Academic Health Centers for Integrative Medicine (293-294)

Appendix C: Table 1-1 List of Abbreviations (295-295)

Appendix D: Liaison Panel Organizations (296-297)

Appendix E: Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice (298-306)

Appendix F: National Center for Complementary and Alternative Medicine Research Centers (307-309)

Appendix G: Public Meetings (310-318)

Appendix H: Committee Biosketches (319-326)

Index (327-338)